510(k) K110434 ยท GEX Powered Laser Surgical Instrument
TRIXEL CO2 LASER
| Applicant | BEIJING SYNTECH LASER CO., LTD., Shanghai, CN |
| Decision | Substantially Equivalent, Apr 19, 2011 |
| Received | Feb 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110434
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.